概览
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This Short Course will be offered virtually – Join from anywhere!
An Aggregate Safety Assessment Planning (ASAP) process is critical to ensure collection and assessment of product level data to answer key safety questions from various stakeholders. In addition, the ASAP process strengthens safety signal detection as well as risk identification and management. The Drug Information Association–American Statistical Association Interdisciplinary Safety Evaluation (DAISE) scientific working group (now one of the ASA Biopharm Safety Monitoring working groups) has proposed an ASAP template to guide sponsor teams in clinical development. This short course will describe how the ASAP supports multidisciplinary safety planning, ongoing aggregate safety evaluation, IND safety reporting decisions, and evaluation of product level safety data and the Safety Topics of Interest, which have the potential to influence a product’s benefit risk assessment.
Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!